A Study to Evaluate the Efficacy and Safety of TAK-906 in Adult Participants With Symptomatic Idiopathic or Diabetic Gastroparesis

NCT03544229 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: TAK-906-20022018-001275-21U1111-1211-2779
• Study Type: interventional
• Target: 242
• Locations: 4 countries
• Sites: 109

Brief Summary

The purpose of this study is to assess the efficacy and safety of treatment with 2 dose levels of TAK-906 in adult participants with gastroparesis compared with placebo during 12 weeks of treatment.

Conditions

Diabetic Gastroparesis; Idiopathic Gastroparesis

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) Composite Score at Week 12 of the Treatment Period

  ANMS GCSI-DD is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in gastroparesis. The ANMS GCSI-DD composite score included score of nausea, early satiety, upper abdominal pain, and postprandial fullness. The severity scores of these symptoms range from 0 (none) to 4 (very severe). The daily composite score was calculated by summing the scores on the 4 symptom items (nausea, early satiety, postprandial fullness, and upper abdominal pain) and then dividing by 4, that is the number of items within the composite score. Thus, the maximum daily composite score was (4 symptoms × maximum score 4 divided by 4) = 16/4 = 4. The ANMS GCSI-DD daily composite score ranged from 0 to 4 with higher scores reflecting greater symptom severity. The negative change from baseline indicates improvement. Mixed-effects Model for Repeated Measures (MMRM) was used for the analysis.

  Baseline and Week 12

Secondary Outcomes (11)

• Percentage of Participants With at Least 50% Reduction From Baseline in ANMS GCSI-DD Composite Score at Week 12

  Baseline and Week 12

• Change From Baseline in the ANMS GCSI-DD Nausea Symptom Score at Week 12 of the Treatment Period

  Baseline and Week 12

• Change From Baseline in the ANMS GCSI-DD Early Satiety Symptom Score at Week 12 of the Treatment Period

  Baseline and Week 12

• Change From Baseline in the ANMS GCSI-DD Postprandial Fullness Symptom Score at Week 12 of the Treatment Period

  Baseline and Week 12

• Change From Baseline in the ANMS GCSI-DD Upper Abdominal Pain Symptom Score at Week 12 of the Treatment Period

  Baseline and Week 12

Study Arms (4)

Placebo

PLACEBO COMPARATOR

TAK-906 maleate placebo-matching capsules, orally, twice daily (BID) for up to 12 weeks.

Drug: Placebo

TAK-906 Maleate 5 mg

EXPERIMENTAL

TAK-906 maleate 5 mg, capsules, orally, BID for up to 12 weeks.

Drug: TAK-906 Maleate

TAK-906 Maleate 25 mg

EXPERIMENTAL

TAK-906 maleate 25 mg, capsules, orally, BID for up to 12 weeks.

Drug: TAK-906 Maleate

TAK-906 Maleate 50 mg

EXPERIMENTAL

TAK-906 maleate 50 mg, capsules, orally, BID for up to 12 weeks.

Drug: TAK-906 Maleate

Interventions

TAK-906 Maleate DRUG

TAK-906 maleate capsules.

TAK-906 Maleate 25 mg; TAK-906 Maleate 5 mg; TAK-906 Maleate 50 mg

Placebo DRUG

TAK-906 maleate placebo-matching capsules.

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Should have experienced symptoms of gastroparesis (e.g., postprandial fullness, nausea, vomiting, upper abdominal pain, and early satiety for at least 3 months before screening as assessed by a physician.
• Must have confirmed delayed gastric emptying by meeting 1 of the following criteria:
• Confirmed by an accepted diagnostic testing method (Gastric Emptying Breath Test \[GEBT\], scintigraphy, or wireless motility capsule) that is documented in the participant's medical records prior to screening; OR
• Participants without previous confirmation of delayed gastric emptying prior to screening will undergo a GEBT after they have stopped taking prohibited medications.
• Must have an average composite ANMS GCSI-DD symptom score ≥2 during the 7 days before randomization. The predominant symptom experienced by participants must not be abdominal pain.
• Must experience nausea: nausea subscale (of ANMS GCSI-DD) symptom score ≥2 at least 4 of 7 days or an average nausea subscale symptom score ≥2 during the 7 days before randomization. Nausea symptoms must not be attributable to a central disorder (e.g. motion sickness, glaucoma, menstrual cycles, migraine headache).
• Has a body mass index (BMI) of ≥18 to ≤40 kg/m\^2 inclusive.
• Participant with diabetes mellitus must have glycosylated hemoglobin (HbA1c) ≤11% at screening and before randomization.
• Absence of gastric outlet obstruction confirmed by upper GI, computed tomography or endoscopy.

You may not qualify if:

• Known secondary causes of gastroparesis including but not limited to Parkinson disease, cancer, viral illness, or connective tissue diseases.
• Predominant gastroparetic symptom is epigastric pain, diffuse abdominal pain, or pain associated with bowel movement.
• Is taking medications that affect gastric emptying including opioids, glucagon-like peptide-1 analogs (e.g., exenatide, liraglutide), amylin analogs (e.g., pramlintide), and cannabinoids.
• Prior history of gastric surgery, including but not limited to gastrectomy, gastric bypass, gastric banding, bariatric surgery, pyloroplasty, vagotomy, or fundoplication, which has manipulated the natural anatomy of the stomach.
• History of intra-pyloric botulinum toxin injection within 3 months of Screening or currently has functioning implantable electric stimulator.
• Nasogastric, percutaneous endoscopic gastrostomy, or percutaneous endoscopic jejunostomy feeding tube or inpatient hospitalization for gastroparesis within 2 weeks before the Screening Visit.
• Required parenteral nutrition for treatment of gastroparesis within 2 months before the Screening Visit.
• Previous diagnosis of gastric bezoar (the presence of retained liquid, bile, or small amounts of poorly organized food residue is permitted).
• Poor control of diabetes within 30 days prior to randomization, including diabetic ketoacidosis, hypoglycemia requiring medical intervention, admission for control of diabetes or diabetic complications.
• Elevated serum prolactin (\>upper limit of normal \[ULN\]) at Screening.
• Has concurrent hypogonadism, current clinically significant menstrual abnormalities, such as amenorrhea or oligomenorrhea, or other clinical features of hyperprolactinemia such as galactorrhea or gynecomastia.
• Has acute or chronic liver disease meeting any of the criteria described below:
• Has an alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin \>2.0 times the ULN.
• Has pre-existing liver cirrhosis that meets Child-Pugh Class B (moderate; total score 7 to 9 points) or C (severe; total score 10 to 15 points) (see Appendix B).
• Has acute or chronic hepatitis B or C virus infection, manifesting as one of the following at screening:

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead

Study Sites (109)

Digestive Health Specialists of the Southeast

Dothan, Alabama, 36305, United States

Location

Del Sol Research Management

Tucson, Arizona, 85710, United States

Location

Del Sol Research Management

Tucson, Arizona, 85745, United States

Location

GW Research

Chula Vista, California, 91910, United States

Location

Trial Connections - New Hope Research Development

Corona, California, 92882, United States

Location

Paragon Rx Clinical - Garden Grove

Garden Grove, California, 92840, United States

Location

Torrance Clinical Research Institute Inc.

Lomita, California, 90717, United States

Location

California Medical Research Associates

Northridge, California, 91324, United States

Location

ISS - Conquest Clinical Research

Orange, California, 92866, United States

Location

Precision Research Institute

San Diego, California, 92114, United States

Location

Connecticut Clinical Research Foundation

Bristol, Connecticut, 06010, United States

Location

ISS - Innovative Research of West Florida

Clearwater, Florida, 33756, United States

Location

Elias Research Associates - Direct Helpers Research Center - Hialeah

Hialeah, Florida, 33012, United States

Location

International Research Associates

Hialeah, Florida, 33012, United States

Location

Palmetto Research

Hialeah, Florida, 33016, United States

Location

Homestead Associates in Research

Homestead, Florida, 33032, United States

Location

Gastroenterology Associates - Crystal River

Inverness, Florida, 34452, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Baptist Diabetes Associates Research

Miami, Florida, 33156, United States

Location

PharmaSouth Research

Miami, Florida, 33175, United States

Location

Miami Dade Medical Research Institute

Miami, Florida, 33176, United States

Location

Anchor Medical Research

Miami, Florida, 33186, United States

Location

Advanced Research Institute - New Port Richey

New Port Richey, Florida, 34653, United States

Location

Advanced Medical Research Center

Port Orange, Florida, 32127, United States

Location

Summit Clinical Research

Athens, Georgia, 30607, United States

Location

Digestive Healthcare of Georgia - Atlanta

Atlanta, Georgia, 30309, United States

Location

DM Clinical Research - Southwest Gastroenterology - Oak Lawn

Oak Lawn, Illinois, 60453, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Tri-State Gastroenterology Associates

Crestview Hills, Kentucky, 41017, United States

Location

Gastro Center of Maryland

Columbia, Maryland, 21045, United States

Location

MGH Digestive Healthcare

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Veterans Affairs Medical Center - West Roxbury

West Roxbury, Massachusetts, 02132, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Clinical Research Institute of Michigan

Chesterfield, Michigan, 48047, United States

Location

Gastroenterology Associates of Western Michigan

Wyoming, Michigan, 49519, United States

Location

Gastrointestinal Associates and Endoscopy Center

Flowood, Mississippi, 39232, United States

Location

Montana Medical Research

Missoula, Montana, 59808, United States

Location

Lovelace Scientific Resources - Albuquerque

Albuquerque, New Mexico, 87108, United States

Location

NY Scientific

Brooklyn, New York, 11235, United States

Location

Long Island Gastrointestinal Research Group

Great Neck, New York, 11023, United States

Location

Atrium Health

Charlotte, North Carolina, 28204, United States

Location

Chevy Chase Clinical Research

Concord, North Carolina, 28025, United States

Location

Fayetteville Gastroenterology Associates

Fayetteville, North Carolina, 28304, United States

Location

Carolina Digestive Diseases

Greenville, North Carolina, 27834, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

PMG Research of Salisbury

Salisbury, North Carolina, 28144, United States

Location

Trial Management Associates

Wilmington, North Carolina, 28403, United States

Location

Gastroenterology Associates of the Piedmont

Winston-Salem, North Carolina, 27103, United States

Location

Consultants for Clinical Research

Cincinnati, Ohio, 45219, United States

Location

Providence Health Partners - Center for Clinical Research

Dayton, Ohio, 45439, United States

Location

Elite Research - Lynn Institute of Stillwater

Stillwater, Oklahoma, 74074, United States

Location

Options Health Research

Tulsa, Oklahoma, 74104, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Digestive Disease Associates - Wyomissin

Wyomissing, Pennsylvania, 19610, United States

Location

ClinSearch

Chattanooga, Tennessee, 37421, United States

Location

Clinical Research Solutions - Jackson

Jackson, Tennessee, 38305, United States

Location

New Phase Research and Development

Knoxville, Tennessee, 37909, United States

Location

Quality Medical Research

Nashville, Tennessee, 37211, United States

Location

Texas Tech University Health Sciences Center - El Paso

El Paso, Texas, 79905, United States

Location

Spring Gastroenterology Associates - Houston

Houston, Texas, 77002, United States

Location

Biopharma Informatic Houston 1

Houston, Texas, 77043, United States

Location

Biopharma Informatic Houston 2

Houston, Texas, 77084, United States

Location

Rio Grande Gastroenterology

McAllen, Texas, 78503, United States

Location

Clinical Associates in Research Therapeutics of America

San Antonio, Texas, 78212, United States

Location

Sun Research Institute

San Antonio, Texas, 78215, United States

Location

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, 23320, United States

Location

Universiteit Antwerpen

Edegem, Antwerpen, 2650, Belgium

Location

Universitair Ziekenhuis Leuven

Leuven, Flemish Brabant, 3000, Belgium

Location

Algemeen Ziekenhuis Sint-Lucas

Bruges, West-vlaanderen, 8310, Belgium

Location

AZ Groeninge Campus Kennedylaan

Kortrijk, West-vlaanderen, 8500, Belgium

Location

Hopital Erasme

Brussels, 1070 Bruxelles, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Universiteit Gent

Ghent, 9000, Belgium

Location

Tokai Memorial Hospital

Kasugai-shi, Aichi-ken, 487-0031, Japan

Location

Meitetsu Hospital

Nagoya, Aichi-ken, 451-8511, Japan

Location

Chubu-Rosai Hospital

Nagoya, Aichi-ken, 455-8530, Japan

Location

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

Location

Tokatsu Tsujinaka Hospital

Abiko, Chiba, 270-1168, Japan

Location

Matsuyama Shimin Hospital

Matsuyama, Ehime, 790-0067, Japan

Location

Hatakeyama Clinic

Fukuoka, Fukuoka, 810-0024, Japan

Location

Oishi Clinic

Kasuya-gun, Fukuoka, 811-2310, Japan

Location

Igarashi Internal Medicine Surgery Clinic

Kōriyama, Fukushima, 963-8026, Japan

Location

Asahi University Hospital

Gifu, Gifu, 500-8523, Japan

Location

Nakamura Digestive Organ Internal Medicine Clinic

Bibai, Hokkaido, 072-0012, Japan

Location

Akakura GI Clinic

Sapporo, Hokkairdo, 060-0807, Japan

Location

Hyogo Prefectural Nishinomiya Hospital

Nishinomiya, Hyōgo, 662-0918, Japan

Location

Hyogo College of Medicine Hospital

Nishinomiya, Hyōgo, 663-8501, Japan

Location

Takarazuka City Hospital

Takarazuka-shi, Hyōgo, 665-0827, Japan

Location

Hitachi, Ltd. Hitachinaka General Hospital

Hitachi, Ibaraki, 312-0057, Japan

Location

Minami Akatsuka Clinic

Mito, Ibaraki, 311-4153, Japan

Location

Tsuchiura Beryl Clinic

Tsuchiura, Ibaraki, 300-0062, Japan

Location

Medical Corporation Shintoukai Yokohama Minoru Clinic

Yokohama, Kanagawa, 232-0064, Japan

Location

Takatsuki Red Cross Hospital

Takatsuki-shi, Osaka, 569-1096, Japan

Location

Medical Corporation Kumagaya General Hospital

Kumagaya, Saitama, 360-8567, Japan

Location

Wakasa Clinic

Tokorozawa, Saitama, 359-1151, Japan

Location

Community Hospital Koga Hospital

Yaizu, Shizuoka, 425-0088, Japan

Location

Shimokitazawa Tomo Clinic

Setagaya-Ku, Tokyo, 155-0031, Japan

Location

Morinaga Ueno Clinic

Kumamoto, 860-0863, Japan

Location

Ijinkai Takeda General Hospital

Kyoto, 601-1495, Japan

Location

Okayama Saiseikai General Hospital

Okayama, 700-8511, Japan

Location

Medical Corporation Kamata Clinic

Saitama, 330-0064, Japan

Location

Gastroenterology and Internal Medicine, Oizumi Medical Clinic

Yamagata, 990-0832, Japan

Location

VITAMED Galaj i Cichomski spolka jawna

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079, Poland

Location

Centrum Medyczne Clw-Med Aneta Cichomska i Joanna uka-Wendrowska sp.j.

Grudziądz, Kuyavian-Pomeranian Voivodeship, 86-300, Poland

Location

Bodyclinic

Warsaw, Masovian Voivodeship, 00-332, Poland

Location

Centrum Medyczne Lukamed Joanna Luka

Chojnice, Pomeranian Voivodeship, 89-600, Poland

Location

Endoskopia

Sopot, 81-756, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej - Witamed Poradnia Diabetolo

Kielce, Świętokrzyskie Voivodeship, 25-035, Poland

Location

Related Publications (2)

• Tack J, McCallum R, Kuo B, Huh SY, Zhang Y, Chen YJ, Mehrotra S, Parkman HP. Randomized clinical trial: A phase 2b controlled study of the efficacy and safety of trazpiroben (TAK-906) for idiopathic or diabetic gastroparesis. Neurogastroenterol Motil. 2023 Oct;35(10):e14652. doi: 10.1111/nmo.14652. Epub 2023 Aug 3.

  PMID: 37533380 DERIVED

• Yamaguchi T, Kudou K, Okamoto H, Chen C, Whiting R, Sekino H. Evaluating the Safety, Tolerability, and Disposition of Trazpiroben, a D2 /D3 Receptor Antagonist: Phase I Single- and Multiple-Ascending Dose Studies in Healthy Japanese Participants. Clin Pharmacol Drug Dev. 2022 Jun;11(6):695-706. doi: 10.1002/cpdd.1057. Epub 2021 Dec 29.

  PMID: 34967147 DERIVED

Related Links

• Related Info

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2018
• First Posted: June 1, 2018
• Study Start: October 14, 2018
• Primary Completion: June 14, 2021
• Study Completion: July 15, 2021
• Last Updated: November 16, 2022
• Results First Posted: November 16, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

BE (7); PL (6); JP (29); US (67)